Vitamin D Supplementation in PCOS Patients (PCOvit-D)

April 30, 2022 updated by: Ayman S Dawood, MD, Tanta University

Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?

To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Algharbia
      • Tanta, Algharbia, Egypt, 31111
        • Ayman Shehata Dawood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS
  • Infertile
  • Vitamin D deficient

Exclusion Criteria:

  • Age less than 20 and more than 35
  • Non PCOS patients
  • Obese patients
  • Previous ovarian surgery
  • Previous oophrectomy of one ovary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vitamin D group
These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study
Drug: Vitamin D
receive 6000iu daily for 8 weeks
PLACEBO_COMPARATOR: Placebo group
These group will receive placebo for the same periods of study group
Drug: Placebo Oral Tablet
placebo for the same period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: 3 months
Number of mature follicles obtained
3 months
Pregnancy rate
Time Frame: 3 months
Number of patients who get pregnant
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

March 30, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 30, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOvit-D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share results

IPD Sharing Time Frame

3 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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